ClinicalTrials.gov record NCT06978738

UCAR T-cell Therapy Targeting CD19/ BCMA in Patients With Relapse/ Refractory Autoimmune Diseases

Record copied from ClinicalTrials.gov: Oct 10, 2026AI summaries generated: Jul 27, 2026

A Clinical Study Evaluating the Safety and Preliminary Efficacy of Universal Allogeneic CAR T-cell Therapy Targeting CD19 and BCMA in Patients With Relapse/Refractory Autoimmune Diseases

StatusNot yet recruitingThe study has been registered but has not started enrolling. Sites and contacts may not be listed yet.
Study typeInterventionalA study in which researchers assign participants to one or more interventions, such as a drug, procedure, device, behavioural programme or other approach, to measure their effects.
PhasePhase 1An early-stage study, usually small, mainly to check safety, side effects and how much of a treatment can be given. Whether it works is not the main question yet.
Age18 years old and older
SexAll
LocationChina
AI summaryWhat this study is about, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

This Phase 1 study tests a single intravenous infusion of universal (allogeneic) anti-CD19/BCMA CAR T-cells in adults (≥18) with relapsed or refractory autoimmune diseases. The CAR T infusion is given after a short course of lymphodepleting chemotherapy (fludarabine and cyclophosphamide). The study will monitor safety and collect early measures of disease response over follow-up.

What it is studying. The study is testing the safety and preliminary activity of one infusion of universal allogeneic anti-CD19/BCMA CAR T-cells in adults whose autoimmune disease has relapsed or not responded to prior treatments.

What the researchers hope to learn. To evaluate safety, including dose-limiting toxicities and overall adverse events. To gather initial evidence of disease responses across the listed autoimmune conditions using disease-specific measures during follow-up.

What this study is about

The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.

This is an investigator-initiated trial to evaluate the safety and efficacy of universal allogeneic anti-CD19/BCMA CAR T-cells in With Relapse/Refractory Autoimmune Diseases.

Interventions being studied

Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.

Biological
  • universal allogeneic anti-CD19/BCMA CAR T-cells

Eligibility

The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.

Inclusion criteria

  • Age ≥ 18 years old (inclusive), regardless of gender.
  • Positive expression of CD19 on peripheral blood B cells confirmed by flow cytometry.
  • Functional requirements for major organs are as follows:
  • Bone marrow function must meet: A. Neutrophil count ≥ 0.5×10 \^ 9/L (no colony-stimulating factor treatment within 2 weeks before examination); B. Hemoglobin ≥ 60g/L; C. Platelets ≥ 30 × 10 \^ 9/L.
  • Liver function: Alanine aminotransferase (ALT) ≤ 3×ULN (excluding ALT elevation due to inflammatory myopathy), aspartate aminotransferase (AST)≤3×Upper limit of normal (ULN) (excluding AST elevation due to inflammatory myopathy), TBIL≤1.5×ULN (or ≤ 3.0×ULN for subjects with Gilbert syndrome);
  • Renal function: creatinine clearance rate (CrCl) ≥ 30ml/minute (calculated by Cockcroft/Gault formula, acute CrCl decrease due to the target disease is excluded; LN is exluded);
  • ECOG score 0-1.
  • Female subjects of childbearing potential and male subjects with partners of childbearing potential must use medically approved contraception or abstinence during the study treatment period and for at least 6 months after the end of the study treatment; Female subjects of childbearing potential must have a negative Human chorionic gonadotropin (HCG) test within 7 days before study enrollment and not be lactating.
  • Willing to participate in this clinical study, sign an informed consent form, have good compliance, and cooperate with follow-up.
  • Subjects with relapsed or refractory autoimmune diseases, Including relapsed or refractory Autoimmune Hemolytic Anemia, relapsed or refractory Systemic Lupus Erythematosus, relapsed or refractory or Progressive Systemic Sclerosis, relapsed or refractory or Progressive Inflammatory Myopathy, relapsed or refractory ANCA-Associated Vasculitis, relapsed or refractory Immunoglobulin-G4 related disease and relapsed or refractory Myasthenia Gravis.

Exclusion criteria

  • Subjects with a history of severe drug allergies or allergic constitutions;
  • Presence or suspicion of uncontrolled or treatment-required fungal, bacterial, viral, or other infections;
  • Subjects with insufficient cardiac function;
  • Subjects with congenital immunoglobulin deficiencies;
  • Subjects with a history of malignant tumors within the past five years, except for the following conditions: non-melanoma skin cancer, stage I tumors with a low recurrence probability after complete resection, clinically localized prostate cancer after treatment, cervical carcinoma in situ confirmed by biopsy or squamous intraepithelial lesion shown by smear, and stable papillary thyroid carcinoma or follicular thyroid carcinoma.
  • Subjects who are positive for hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) with peripheral blood HBV DNA >ULN; subjects positive for hepatitis C virus (HCV) antibody and peripheral blood HCV RNA; individuals positive for human immunodeficiency virus (HIV) antibody; individuals positive for syphilis testing;
  • Subjects with mental illness and severe cognitive dysfunction;
  • Pregnant women or women planning to conceive;
  • Subjects whom the investigator believes have other reasons that make them unsuitable for inclusion in this study.

Study description and what participation involves

The study's detailed description, as published on ClinicalTrials.gov.

Detailed description from the registry

This is an investigator-initiated trial to evaluate the safety and efficacy ofuniversal allogeneic anti-CD19/BCMA CAR T-cells in Patients With Relapse/Refractory Autoimmune Diseases. Study intervention consists of a single infusion of universal allogeneic CART-cells administered intravenously after a lymphodepleting therapy regimen consisting of fludarabine and cyclophosphamide.

AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

After screening and baseline assessments, participants receive lymphodepleting chemotherapy (fludarabine and cyclophosphamide) followed by a single intravenous infusion of the universal allogeneic anti‑CD19/BCMA CAR T‑cells. They will have close safety monitoring immediately after infusion (including assessments within the first 28 and 90 days) and regular follow‑up visits and disease activity assessments for up to 24 months. Assessments include blood tests, recording of adverse events, and disease‑specific activity scores (for example SLEDAI, mRSS, MG‑ADL/QMG, BVAS, IgG4‑RD RI, or myositis TIS). The registry record does not list additional procedures such as biopsies or imaging beyond these planned assessments.

How the study is structured. Phase 1 interventional treatment trial. Single-group, no masking (everyone receives the study treatment; no placebo or comparison arm). Participants receive lymphodepleting chemotherapy (fludarabine and cyclophosphamide) then one intravenous infusion of UCAR anti-CD19/BCMA CAR T-cells and are followed and monitored for side effects and disease measures for months to years.

Questions you could ask

These questions are suggestions for a conversation with the study team or your own clinician, not advice.

  • This is an early-phase study, mainly about safety and dose. What is already known about this treatment?
  • The registry says recruitment has not started. When is it expected to open, and can I register interest now?
  • The listed sites are in China. Is any of them reachable for me, and does the study help with travel?
  • Which of the eligibility criteria would need to be checked with tests before I could join?

More on IgG4-related disease

This trial is also listed on this site under autoimmune hemolytic anemia.

Clinical trials32 trials listed for IgG4-related diseaseEvery trial the registry lists for IgG4-related disease, with recruitment status, phase and sites, updated from ClinicalTrials.gov.See all trials →Research updatesWhat changed in IgG4-related disease researchLatest monthly update: September 2026. Includes: Relapse prevention trial. New research summarized each month in plain language, with links to every source paper.Read the latest update →

Important dates

Study start
May 2025 (estimated)
Primary completion
May 2027 (estimated)
Study completion
November 2028 (estimated)
Target enrollment
18 participants (estimated)
Last updated on registry
May 18, 2025
Data verified
Oct 10, 2026

Sponsor and research team

The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.

Lead sponsor
Changzhou No.2 People's Hospital
Principal investigator
Lu Xuzhang, Principal Investigator
Changzhou No.2 People's Hospital

Central study contact

If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.

Participating sites (1)

Terms used on this page · explanations by MedicalUpdates.ai

CAR T
A treatment in which a person's own immune cells (T cells) are collected, modified in a laboratory to recognise a target, and returned to the body.
Relapse
A condition that improved with treatment and has since returned or worsened.
Refractory
A condition that has not responded to a treatment. 'Relapsed' means it responded and then came back; 'refractory' means it did not respond in the first place.
Neutrophil count
The number of neutrophils, a type of white blood cell that fights infection, in a blood sample. Studies often require it to be above a set level.
ULN
The highest value of a blood test that a laboratory considers normal. Criteria such as '≤ 3 × ULN' mean the result must be no more than three times that value.
creatinine clearance
A measure of kidney function, calculated from a blood creatinine level together with age, weight and sex.
ECOG score
A scale from 0 to 5 that describes how a person's condition affects daily activity. 0 means fully active; 1 means restricted in strenuous activity; 2 means able to self-care but unable to work; higher numbers mean more limitation.
childbearing potential
Studies often ask participants who could become pregnant, or could father a child, to use contraception during the study and for a period afterwards, because the effect of the treatment on a pregnancy is unknown.
enrollment
The number of participants a study plans to include, or has included. 'Estimated' means the planned number; 'actual' means the number who joined.
informed consent form
The process of explaining a study, including its risks and what participation involves, so that a person can decide freely whether to take part. Consent is usually documented in writing, and a participant can choose to leave the study later.
follow-up
The period after treatment or enrolment during which participants are observed or contacted, for example to record side effects or outcomes.
biopsy
Removal of a small piece of tissue so it can be examined under a microscope. 'Biopsy-proven' or 'histologically confirmed' means the diagnosis was confirmed by examining tissue under a microscope.
Inclusion Criteria
The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
Exclusion Criteria
The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.

The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.

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